Corporate Profile

Serum Focus Gives Way to Complete Systems

Thermo Electron and Fisher Scientific merged and formed Thermo Fisher Scientific in 2006. Among Fisher’s product lines at the time of the acquisition was HyClone, a manufacturer of sera, dry powdered media, liquid media, and disposable BioProcess Containers (BPC) for life science researchers and biopharmaceutical manufacturers.

The main campus where Thermo Scientific HyClone products are developed and manufactured remains in Logan, UT. Rex Spendlove, Ph.D., a virologist at Utah State University, started HyClone 40 years ago to supply bovine serum to other scientists working with cell cultures.

Dr. Spendlove pioneered the collection and filtration processes that evolved into the products marketed by the company today. More recent innovations in single-use systems have helped the Thermo Scientific Cell Culture and Bioprocessing unit, which develops and sells the HyClone product line, to become a leader in self-manufactured media, serum, buffers, and single-use technology.

“We migrated from being a supplier of animal serum to being a company that develops, manufactures, and markets complete bioprocessing systems,” says Brandon Pence, director of global marketing at Thermo Scientific Cell Culture and Bioprocessing. Today’s products integrate cell culture media and supplements with unique delivery systems into single-use bioreactors for the production of vaccines and biotherapeutics.

New BioCenter

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Thermo Fisher Scientific technician inspects BioProcess Containers.

In response to increasing demand for single-use bioprocessing products, Thermo Fisher Scientific invested $20 million to build a new BioCenter and expand its existing media and BPC manufacturing facilities in Logan and Cramlington, U.K. BPC can be used for a wide variety of applications, including mixing, storage, and transportation of cell culture media, culturing cells in single-use bioreactors, and harvesting cell culture products.

The BioCenter manufactures simple BPCs as well as complex bioprocessing systems custom designed specifically for clients. The Single-Use Bioreactor and Single-Use Mixer were introduced in 2006 and have reportedly been adopted by more than 80% of the top biopharmaceutical companies.

The first single-use products were media transport bags, which expanded over the years into today’s integrated single-use systems with built-in functionality. For example, single-use bioreactors “have full capabilities like stainless steel bioreactors. You can control temperature, mixing, sparging, and venting,” says Justin Hutchinson, associate director of single-use products at Thermo Scientific Cell Culture and BioProcessing.

The Single-Use Bioreactor uses a BPC placed inside a stainless steel support with attached control systems. “How extravagant the control system becomes depends on what a customer wants to use it for and the functionality added to the BPC,” says Hutchinson. The BPC is replaced after each batch or run, while the stainless steel bioreactor support is reused.

A dry-powder media production facility was the company’s first entry into providing dry powdered media for cell culture applications. A second dedicated animal-free, state-of-the-art micronization pin mill facility opened in 2004. It produces dry powder media for bioproduction clients in batches up to 6,000 kg.

This high-throughput manufacturing system delivers consistent quality from small-scale validation batches to full production lots The pin mill operation blends all the components using continuous micronization and particle size reduction.

Additionally, a computerized, bar-coded weight verification system confirms the accuracy of each formulation. “Even in 6,000 kilogram batches, when you take 10 grams from the batch for sampling, it’s uniform no matter where you collect the sample,” says Hutchinson.

Collaborations

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Technicians at Thermo Fisher Scientific prepare to mix dry powder into liquid media for a large media fill.

Experts at the Thermo Scientific Cell Culture and Bioprocessing unit actively consult with their clients. They examine a client’s processes and make suggestions that include optimizing cell culture media formulations, customizing processes that use feed supplements, and developing bioreactor protocols for growing cells and expressing recombinant proteins and vaccines.

This integration of protocols and services insures performance throughout the manufacturing process. These collaborations produce a custom solution that improves productivity and efficiency. “Developing a custom solution for our clients that delivers productivity gains and process efficiencies is our strength, and is highly valued by our clients,” says Pence.

By combining media and serum products, single-use systems, and customized solutions, Thermo Fisher Scientific sends a message that resonates with customers who are looking for optimal performance. Because the company’s products are critical to the manufacturing of biotherapeutics and vaccines, Thermo Scientific Cell Culture and Bioprocessing business focuses on customer needs to insure quality and performance.

Biotherapeutic Tools

The manufacturing of monoclonal antibodies and other biotherapeutics brings new challenges. Blockbuster drugs like Enbrel and Rituxan are manufactured in cell cultures. “We formulate proprietary media on a custom basis to improve yields for customers,” says Michael Radovan, associate director of media and sera at Thermo Scientific Cell Culture and BioProcessing unit.

Clients who manufacture biotherapeutics need not only platform media solutions, but also feed supplements to extend production runs for 7 to 10 days longer than normal to boost yields. Thermo Fisher Scientific customizes solutions to improve yields and provide proprietary formulations.

As biotherapeutics start to lose their patent protection, other companies are gearing up to manufacture biosimilars. These clients want platforms designed now that can be up and running quickly to jump start their entry into the biosimilar market.

Biotechnology companies advancing stem cell research and developing cellular therapies require smaller batches for preclinical testing and clinical trials. For personalized medicine, individual patients may even need their own cell line developed. The Single-Use Bioreactor is an ideal solution for production of stem cell therapies, because it enables consistent batches of 25 to 2,000 liters.

In addition to the facility in Logan, UT, the Thermo Scientific Cell Culture and Bioprocessing unit serves clients worldwide through serum-processing sites in New Zealand and Australia, a liquid media and BPC production site in Cramlington, U.K., and a liquid media production facility in Beijing, China.

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